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The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin-coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.

The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

Here's a breakdown of the acceptance criteria and the study information for the NOVEOS Specific IgE (sIgE) Assay, Capture Reagent M006, Alternaria alternata, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

2. Sample sizes used for the test set and the data provenance:

• Clinical Performance Comparison to ImmunoCAP:

  • Sample Size: 257 samples
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies laboratory testing of human serum samples. The study is presented as part of a 510(k) submission, typically indicating data relevant for regulatory approval.
  • Retrospective/Prospective: Not explicitly stated.

• Clinical Performance (vs. Clinical Diagnosis):

  • Sample Size: 182 patients (65 with allergic status confirmed by skin-prick testing and clinical history, 117 from healthy, non-atopic donors).
  • Data Provenance: Not explicitly stated (e.g., country of origin).
  • Retrospective/Prospective: Not explicitly stated.

• Precision/Reproducibility:

  • Sample Size: Six samples (1 negative, 3 positive patient samples, 2 controls), each assayed for 80 replicates total (2 runs/day for 20 days, duplicate replicates).
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Not explicitly stated, likely prospective laboratory testing.

• Lot-to-Lot Imprecision:

  • Sample Size: Six samples, each assayed for 240 replicates total (3 different lots, 2 replicates/run, 2 runs/day for 20 days).
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Not explicitly stated, likely prospective laboratory testing.

• Site-to-Site Reproducibility:

  • Sample Size: 6 samples (4 patient pools and 2 controls), each tested for 75 replicates total (5 replicates/run, 1 run/day for 5 days, across 3 sites).
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Not explicitly stated, likely prospective laboratory testing.

• Linearity:

  • Sample Size: Dilutions of M006 specific IgE samples with analyte concentrations from 0.17 to 41.9 kU/L. The number of individual samples/dilutions used for the regression is not explicitly stated, but the range is.
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Not explicitly stated, likely prospective laboratory testing.

• Detection Limit (LoB, LoD, LoQ):

  • Sample Size: 60 replicates of analyte-free samples, 300 replicates of low IgE samples (for LoB/LoD). For LoQ, a panel of seven low analyte samples was assayed in 80 replicates total (replicates of two, 2 runs/day for 20 days).
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Not explicitly stated, likely prospective laboratory testing.

• Reference Range:

  • Sample Size: 127 apparently healthy subjects.
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• For the Clinical Performance vs. Clinical Diagnosis study: The allergic status of 65 samples was confirmed by "skin-prick testing and clinical history." This implies that the ground truth was established by medical professionals (allergy specialists, physicians) who conduct these tests and histories, but the number and specific qualifications of these experts are not mentioned.
• For other studies (e.g., ImmunoCAP comparison, precision, linearity), the ground truth is based on the performance of the predicate device, or established values in quality control materials, or analytical measurements, rather than expert interpretation of individual cases.

4. Adjudication method for the test set:

• For the Clinical Performance vs. Clinical Diagnosis study: The text states "allergic status was confirmed by skin-prick testing and clinical history." This suggests a consensus-based approach by the clinicians involved in the diagnosis, but no formal adjudication method (e.g., 2+1, 3+1) is described.
• For the ImmunoCAP comparison study, the "ground truth" is the result from the ImmunoCAP predicate device. No expert adjudication is applicable in this context.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) immunoassay for quantitative measurement of IgE, not an AI-powered image analysis or diagnostic assist device where human readers would be involved in interpreting results in combination with the device's output. The device produces quantitative values directly.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, this is a standalone device in the context of its intended use. The NOVEOS Specific IgE Assay, used with the NOVEOS Immunoassay Analyzer, is an automated system that "automatically generate results" for allergen-specific IgE levels. It directly provides a quantitative measurement. While the interpretation of these results for clinical diagnosis requires a trained clinician ("in conjunction with other clinical findings"), the device itself operates as a standalone analytical tool.

7. The type of ground truth used:

• Clinical Performance vs. ImmunoCAP: The ground truth was the results from the legally marketed predicate device (ImmunoCAP Specific IgE).
• Clinical Performance vs. Clinical Diagnosis: The ground truth was established by expert clinical diagnosis based on "skin-prick testing and clinical history."
• Precision/Reproducibility: The ground truth is inherent in the known values of controls and patient samples for measuring variability.
• Linearity/Detection Limits: The ground truth is based on analytically determined concentrations/dilutions of samples.
• Reference Range: The ground truth for healthy individuals was defined by testing samples from "apparently healthy subjects" to establish expected physiological levels.
• Interference/Cross-Reactivity/Competitive Inhibition: Ground truth derived from known concentrations of interfering substances or related/unrelated allergens to assess their impact on assay performance.

8. The sample size for the training set:

• The document describes performance studies for a diagnostic assay, not a machine learning algorithm that typically requires a large training set. Therefore, there is no "training set" in the sense of an ML model being trained on data. The studies and samples described are for validation and verification of the assay's analytical and clinical performance.

9. How the ground truth for the training set was established:

• As indicated in point 8, there isn't a "training set" in the conventional machine learning sense for this type of IVD immunoassay. The device's underlying principles are based on established immunometric and chemiluminescent assay technologies, not a data-driven learning algorithm. The "ground truth" for calibrators and controls used in the analytical process is established through rigorous laboratory methods, often traceable to international reference standards like the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234, as mentioned in the "Calibrator Traceability" section.

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